Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-28 @ 7:09 PM
Study NCT ID:
NCT02181335
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2014-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study Comparing Respimat ® Budesonide With Turbohaler ® Budesonide in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Twelve-week, Efficacy and Safety Study Comparing Respimat ® Budesonide (100 and 200 mcg, 2 Puffs Bid) With Turbohaler ® Budesonide (200 mcg, 2 Puffs Bid) in Symptomatic Adult Moderate to Severe Asthmatic Requiring Inhaled Corticosteroids and Bronchodilator Therapy.
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To establish that at least one of the two doses of Budesonide, as an ethanolic solution inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200 mcg, 2 puffs bid) and that the safety profile is at least as good
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: